Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study

NCT02650791 | Completed Phase 3 DMC

• 1 other identifier: 20150629-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with therapeutic platelet transfusions is safe and effective compared to prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (who are at risk for bleeding).

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (4)

• Enrolment, as measured by the number of patients screened per month at each site

  monthly, up to 23 months

• Number of off-protocol platelet transfusions, with a target of < 10% off-protocol transfusions in each treatment arm

  monthly, up to 23 months

• Total number of platelet transfusions/group, with a target of 25% reduction in the tranexamic acid arm

  monthly, up to 23 months

• Adherence to tranexamic acid use, defined as excellent (greater than or equal to 90% use), acceptable (75-90% use), poor (< 75% use)

  monthly, up to 23 months

Secondary Outcomes (12)

• WHO (World Health Organization) Bleeding events of Grade 2 or higher

  daily, up to one month

• Time from randomization to bleeding of WHO bleeding events Grade 2 or higher

  daily, up to one month

• Number of days with bleeding of WHO bleeding events Grade 2 or higher

  daily, up to one month

• Bleeding Severity Measurement Scale for bleeding events Grade 2 or higher

  daily, up to one month

• Number of platelet and/or red cell transfusions

  daily, up to one month

Study Arms (2)

Prophylactic Platelet Transfusions

NO INTERVENTION

Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 10\^9/L.

Prophylactic Tranexamic Acid

EXPERIMENTAL

Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral dose of Tranexamic Acid 1 gram three times daily. Tranexamic Acid will start when Platelet count is less than 50 x 10\^9/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Prophylactic Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients are aged 18 years old or older and undergoing an autologous HSCT (hematopoietic stem cell transplantation) for any hematologic malignancy.

You may not qualify if:

• A previous WHO grade 3 or 4 bleeding event
• A WHO grade 2 bleeding event within the past year
• A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
• Current or previous (within 2 weeks) urinary tract bleeding
• An inherited hemostatic or thrombotic disorder
• Coagulopathy defined as a prothrombin time or activated partial thromboplastin time \>1.5 times the upper limit of normal or fibrinogen less than 2 g/L
• A requirement for therapeutic anticoagulant or antiplatelet drugs
• Previously documented history of refractoriness to platelet transfusion secondary to HLA (Human Leukocyte Antigen) antibodies
• Significant renal impairment (creatinine \>1.5 times the upper limit of normal)
• Pregnant or breast-feeding
• Unwilling or unable to provide informed consent
• Participant has ever had a pulmonary embolism, deep vein thrombosis, cerebral thrombosis or has active angina
• Participant has known history of subarachnoid hemorrhage
• Participant has acquired disturbances to his/her colour vision
• Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (5)

Tom Baker Cancer Centre

Calgary, Alberta, T2N4N2, Canada

Location

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Tay J, Allan D, Beattie S, Bredeson C, Fergusson D, Maze D, Sabloff M, Thavorn K, Tinmouth A. Rationale and design of platelet transfusions in haematopoietic stem cell transplantation: the PATH pilot study. BMJ Open. 2016 Oct 24;6(10):e013483. doi: 10.1136/bmjopen-2016-013483.

  PMID: 27798034 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Alan Tinmouth, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)